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Patients' Rights in the European Union Mapping Exercise Patients’ Rights in the European Union Mapping eXercise Final Report Written by PRE-MAX Consortium March – 2016 EUROPEAN COMMISSION Directorate-General for Health and Food Safety (SANTE) Directorate B Health systems, medical products and innovation Unit B.3 Cross Border Healthcare and eHealth Unit (B3) Contact: Balázs Lengyel E-mail: [email protected] European Commission B-1049 Brussels EUROPEAN COMMISSION Patients’ Rights in the European Union Mapping eXercise Final Report Directorate-General for Health and Food Safety (SANTE) Third Health Programme (2014-2020) 2016 EW-01-17-244-EN-N EUROPE DIRECT is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you) LEGAL NOTICE This document has been prepared for the European Commission however it reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. More information on the European Union is available on the Internet (http://www.europa.eu). Luxembourg: Publications Office of the European Union, 2016 EN ISBN 978-92-79-66960-6 doi: 10.2875/751285 EW-01-17-244-EN-N © European Union, 2016 Reproduction is authorised provided the source is acknowledged. Authors to the report: Maastricht University David Townend Timo Clemens David Shaw Helmut Brand KU Leuven Herman Nys European Observatory on Health Systems and Policies Willy Palm Study on Patients’ Rights in the European Union - MApping eXercise ACKNOWLEDGMENTS This mapping of patients’ rights in 30 European countries was conducted by a consortium of three organizations combining specific expertise in the area of patients’ rights law and policy. These organizations were Maastricht University, KU Leuven and the European Observatory on Health Systems and Policies. In addition, national experts from all EU Member States, Norway and Iceland were involved in the steps of data collection and analysis and provided valuable contributions. The authors gratefully acknowledge the contributions of key experts in Member States and other contributors mentioned below. Key experts involved in data collection (listed in alphabetical order of countries) Verena Stühlinger (Austria), Herman Nys (Belgium), Darina Zinovieva (Bulgaria), Velebit Bozikov (Croatia), Georgia Charalambidou (Cyprus), Lukas Prudil (Czech Republic), Mette Hartlev (Denmark), Tiina Titma (Estonia), Sirpa Soini (Finland), Anne-Marie Duguet (France), Tade Matthias Spranger (Germany), Takis Vidalis (Greece), Judit Sandor (Hungary), Oddny Mjöll Arnardottir (Iceland), Deirdre Madden (Ireland), Giovanni Comandé (Italy), Solvita Olsena (Latvia), Jaunius Gumbis (Lithuania), Mike Schwebag (Luxembourg), Pierre Mallia (Malta), Lisette Bongers (Netherlands), Karl Harald Sovig (Norway), Ewa Baginska (Poland), André Pereira (Portugal), Diana Nacea (Romania), Peter Kovac (Slovakia), Viktorija Žnidaršič (Slovenia), Mayte Teresa Requejo (Spain), Ulrika Sanden (Sweden), David Townend (UK). Other contributors involved through the workshop and other meetings We are grateful to the 25 individual experts and institutional representatives of relevant stakeholders (professional bodies, policy makers, patient advocacies, healthcare professionals, patient organizations, and academia) from national and European level in the area of patients’ rights who discussed with us the preliminary results of the mapping exercise during the workshop on September 10th and 11th 2015 in Brussels. In addition, we would like to thank Laureen Missaire, Wilco Tilburgs and Bilal Shah Syed for their support on parts of the data collection and translations. 1 | P a g e Study on Patients’ Rights in the European Union - MApping eXercise TABLE OF CONTENTS ACKNOWLEDGMENTS ....................................................................................... 1 TABLE OF CONTENTS ....................................................................................... 2 EXECUTIVE SUMMARY ...................................................................................... 3 RÉSUMÉ EXÉCUTIF .......................................................................................... 8 ZUSAMMENFASSUNG ...................................................................................... 13 1. INTRODUCTION ....................................................................................... 18 2. METHODOLOGY ....................................................................................... 21 2.1 General approach ............................................................................... 21 2.2 Literature review and review of funded actions ....................................... 23 2.3 Survey among national experts ............................................................ 24 2.4 Review of Council of Europe activities ................................................... 24 2.5 Workshop .......................................................................................... 25 2.6 Limitations of the study ....................................................................... 25 3. RESULTS ................................................................................................ 26 3.1 Patients’ rights law and enforcement –an overview ................................. 26 3.1.1 General context ............................................................................... 26 3.1.2 Basic individual rights ...................................................................... 29 3.1.3 Consumer based rights ..................................................................... 31 3.1.4 Enforcement and Redress ................................................................. 35 3.2 Patients’ rights law – a country-by-country review .................................. 43 3.3 Enforcement – a country by country review ......................................... 115 3.4 Council of Europe activities ................................................................ 139 3.4.1 The Convention on Human Rights and Biomedicine ............................ 139 3.4.2 The impact of Council of Europe Activities in their countries. ............... 140 APPENDIX .................................................................................................... 141 Annex 1: Survey template (Final Version) ................................................. 141 Annex 2: Identified sources of the literature review.................................... 157 Annex 3: Identified activities from the project review ................................. 185 Annex 5: Programme of the one-day workshop ......................................... 224 Annex 6: Discussion paper D5 ................................................................. 226 2 | P a g e Study on Patients’ Rights in the European Union - MApping eXercise EXECUTIVE SUMMARY This report aims to provide an overview of patients’ rights in all EU Member States, Norway and Iceland by mapping national patients’ rights legislation, soft-law, structures and enforcement procedures ensuring the rights of patients. The mapping exercise was performed from January to September 2015 providing a cross-sectional view of the patients’ rights situation in the 30 countries under study. The mapping exercise included a literature review, a review of activities funded by the EU Health programme, the Research and Innovation Framework Programme and by the European Partnership on Active and Healthy Ageing (EIP-AHA). Furthermore, qualitative assessment of the patients’ rights situation was undertaken by national patients’ rights experts by means of a survey. Preliminary results were presented and discussed with a wide range of relevant stakeholders at a workshop on September 10th and 11th 2015 in Brussels. A conceptual model for this comparative mapping of patients’ rights was developed as a starting point for the assessment. The three domains of patients’ rights assessed cover (1) basic individual rights, (2) consumer- based rights and (3) procedural rights. Basic individual rights cover the right to informed consent; to privacy and dignity; to access to the medical file; and to information on one’s health. Consumer based rights entail the right to choose one’s provider, to a second opinion, to safe and timely treatment (patient safety and quality of care) and to information concerning care options. Procedural rights include the right to complain, to compensation, and to participate in decision-making. However, these different patients’ rights subjects cannot be totally separated from each other. The survey tool assessed the following patients’ rights subjects: (I) the formal recognition of the right and/or the way it is embedded in broader national laws; (II) the implementation of the right in practice; (III) the application of the right in the cross-border context; (IV) the use of the right in practice; and (V) available remedies and procedures when the right is not respected. Furthermore, broader positioning of patients’ rights within the health system and the impact of the Council of Europe’s work on the situation of patients’ rights was assessed. In the area of basic individual rights all Member States, as well as Norway and Iceland, are developing a legal approach to defining and implementing patients’ rights to self-determination and confidentiality (rights to consent and information; privacy; accessing records). This is not
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